Four years after EU approval, NICE finally backs Revlimid use in certain first-line multiple myeloma patients

Four years after the European Commission sanctioned the use of Celgene’s flagship Revlimid to treat adults with previously-untreated multiple myeloma who are not eligible for transplant, England’s National Health Service (NHS) will adopt its use as the first or second line of defense — in certain patients. Although the blockbuster drug is routinely used as a backbone treatment in much of the developed world, until now, the drug was only cleared for third-line use by NICE.

Revlimid, which generated roughly $9.7 billion in global 2018 sales, has long been Celgene’s keystone treatment, but its use in England had been restrained due to pricing disagreements. The drug is also crucial to Bristol-Myer’s $BMY$74 billion bet on the big biotech (although the loss of patent protection is looming).

Multiple myeloma is a life-threatening form of blood cancer, which originates in the bone marrow, and affects roughly 17,500 people in the UK at any given time, according to charity Myeloma UK, which estimates each year that about 5,700 new patients are diagnosed with the disease.

NICE published two pieces of final draft guidance on Friday. In the first report, NICE recommended the use of Revlimid — known chemically as lenalidomide — in combination with the corticosteroid dexamethasone as an option for treatment-naive adults with multiple myeloma who are not eligible for a stem cell transplant and cannot take thalidomide. This new option could benefit about 2,100 patients, NICE said.

Thalidomide (or bortezomib, or Takeda’s $TAK Velcade, for those who can’t take thalidomide) remains the first line of defense, although NICE acknowledged that severe side-effects associated with its use can rule out its adoption. However, “(l)enalidomide plus dexamethasone cannot be recommended for untreated multiple myeloma in people who could take thalidomide because this would not be cost effective,” NICE underscored.

Lenalidomide is available as a 21‑capsule pack, and its cost varies per dose, up to £4,368 for the highest 25 mg dose/pack. But, Celgene $CELG has now agreed to a (confidential) discount that has satisfied NICE.

In the second report, NICE backed the use of lenalidomide as an option for treating multiple myeloma in adults if they have had only one previous therapy, including bortezomib. Particularly for those that have been first treated with bortezomib, the only next treatment in the doctor’s toolbox is chemotherapy — however, evidence indicates that the lenalidomide+dexamethasone is more effective than cytotoxic chemotherapy. In one clinical study, patients taking lenalidomide lived on average 7 months longer, NICE said.

About 320 patients are expected to benefit, it added.

The most ‘plausible’ cost-effectiveness estimate for lenalidomide plus dexamethasone may be above the range that NICE normally considers being a cost-effective use of NHS resources, researchers highlighted in the report, but conceded that since lenalidomide has been recommended for use as a first treatment (for which it is cost-effective) — the need for lenalidomide as a second treatment will likely decrease because people are more likely to have it as a first treatment in the future.

Last month, NICE also backed the use of J&J’s $JNJ Darzalex in combination with Velcade as a second-line treatment for multiple myeloma via the cancer drugs fund.

Celgene, meanwhile, is advancing the use of triplet multiple myeloma therapies. On Thursday, the EU approved 1) Revlimid in combination with Velcade and dexamethasone for adult patients with previously untreated multiple myeloma who are not eligible for transplant; 2) Imnovid in combination with Velcade and dexamethasone in adult patients with multiple myeloma, who have received at least one prior treatment regimen including Revlimid.

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